An official website of the United States government
Home
Name
ADXS-HPV
Alternate Names
axalimogene filolisbac
ADXS11-001
Abbreviations
None
Category
Biologic therapy (BRM, immunotherapy)
Subcategory
None
NSC Number
None
Primary Site
Cervix
Histology
None
Remarks
12/23/2025 update: This was a therapeutic HPV vaccine (different from Gardasil; the prophylactic one) that was under development for HPV associated conditions such as locally advanced cervical cancer, recurrent/refractory cervical cancer, anal cancer, and CIN2/3. Phase I-II trials were completed but the program was discontinued and was never FDA approved.
June 2023: The FDA granted Orphan Drug designation to ADXS-HPV for treatment of stage II-IV invasive cervical cancer. Orphan drug designation is granted to drug therapies intended to treat diseases or conditions that affect fewer than 200,000 people in the US. This drug is currently in several clinical trials showing promising results. Code this drug as Other until final FDA approval is granted.
June 2023: The FDA granted Orphan Drug designation to ADXS-HPV for treatment of stage II-IV invasive cervical cancer. Orphan drug designation is granted to drug therapies intended to treat diseases or conditions that affect fewer than 200,000 people in the US. This drug is currently in several clinical trials showing promising results. Code this drug as Other until final FDA approval is granted.
Coding
Please see remarks for additional information
